Details for New Drug Application (NDA): 206510

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NDA 206510 describes DUTREBIS, which is a drug marketed by Merck Sharp Dohme and is included in one NDA. There are two patents protecting this drug. Additional details are available on the DUTREBIS profile page.

The generic ingredient in DUTREBIS is lamivudine; raltegravir potassium. There are twenty-nine drug master file entries for this compound. Additional details are available on the lamivudine; raltegravir potassium profile page.

Summary for 206510

Tradename:	DUTREBIS
Applicant:	Merck Sharp Dohme
Ingredient:	lamivudine; raltegravir potassium
Patents:	2

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 206510

Generic Entry Date for 206510^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up Dosage: TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	150MG;EQ 300MG BASE
Approval Date:	Feb 6, 2015	TE:		RLD:	No
Patent:	⤷ Sign Up	Patent Expiration:	Apr 3, 2024	Product Flag?		Substance Flag?		Delist Request?
Patent:	⤷ Sign Up	Patent Expiration:	Sep 11, 2029	Product Flag?		Substance Flag?		Delist Request?	Y

Expired US Patents for NDA 206510

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Merck Sharp Dohme	DUTREBIS	lamivudine; raltegravir potassium	TABLET;ORAL	206510-001	Feb 6, 2015	⤷ Sign Up	⤷ Sign Up
Merck Sharp Dohme	DUTREBIS	lamivudine; raltegravir potassium	TABLET;ORAL	206510-001	Feb 6, 2015	⤷ Sign Up	⤷ Sign Up
Merck Sharp Dohme	DUTREBIS	lamivudine; raltegravir potassium	TABLET;ORAL	206510-001	Feb 6, 2015	⤷ Sign Up	⤷ Sign Up
Merck Sharp Dohme	DUTREBIS	lamivudine; raltegravir potassium	TABLET;ORAL	206510-001	Feb 6, 2015	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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Summary for 206510

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 206510

Profile for product number 001

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DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 206510